MedTrace Logo

Trial of ProAgio in Advanced/Metastatic Colorectal Cancer

NCT06867822 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-08-24

No results posted yet for this study

Summary

This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels.

Subjects will be selected based on following criteria: previously untreated advanced/metastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded.

Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.

Conditions

Interventions

DRUG

ProAgio

ProAgio is a pegylated protein with a single pegylated site. The 12,131 Dalton protein is produced in E. coli and is composed of 105 amino acids with no disulfide bonds. The structure of the polyethylene glycol moiety is Methoxy PEG maleimide 30000.

DRUG

FOLFIRI

FOLFIRI is a combination of three drugs: (leucovorian, fluorouracil, and irinotecan) used to treat advanced metastatic colorectal cancer. FOLFIRI is commercially available will be administered using standard dosing regimen as per institutional guidelines.

DRUG

Bevacizumab

Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). Bevacizumab is commercially available and will be administered using standard dosing regimen as per institutional guidelines.

Sponsors & Collaborators

  • The V Foundation

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867822 on ClinicalTrials.gov